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Ovarian CancerPhase 2NCT06787612

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

A Phase 2 study testing Ubamatamab, Bevacizumab and Cemiplimab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Regeneron Pharmaceuticals at 56 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ubamatamab, Bevacizumab and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
397 participants
Where
56 sitesin 5 countries
Study dates
28 May 2025to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
  • Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function, as described in the protocol
  • Platinum-Resistant Ovarian Cancer, as described in the protocol

Who cannot join

  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
  • Another malignancy that is progressing or requires active treatment, as described in the protocol
  • Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
  • Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
  • Moderate to large or ascites, as described in the protocol
  • Bowel obstruction within last 3 months or current need for parenteral nutrition
  • NOTE: Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

56 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

56 sites in 5 countries

United States21 sites, 21 recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Hilliard, Ohio, 43026

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • UC San Diego Health

    La Jolla, California, 92037

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Norton Cancer Institute, St. Matthews Clinic

    Louisville, Kentucky, 40207

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Advent Health Cancer Institute

    Orlando, Florida, 32804

    Recruiting

  • University of Pittsburgh Medical Center, Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • West Penn Hospital of Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Providence Cancer Institute

    Portland, Oregon, 97213

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Avera Cancer Institute Sioux Falls

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Tampa General Hospital Cancer Institute

    Tampa, Florida, 33606

    Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

Turkey (Türkiye)12 sites, 12 recruiting

  • Baskent University

    Adana, 01123

    Recruiting

  • Hacettepe University

    Altındağ, Ankara, 06240

    Recruiting

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100

    Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 06200

    Recruiting

  • Memorial Ankara Hospital

    Ankara, 0906520

    Recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Bornova, İzmir, 35100

    Recruiting

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil, 27584

    Recruiting

  • Medipol University Hospital

    Istanbul, Bagcilar, 34284

    Recruiting

  • Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa

    Istanbul, 34450

    Recruiting

  • Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)

    Izmir, 35575

    Recruiting

  • Sakarya University - Education and Research Hospital

    Sakarya, 54290

    Recruiting

  • Medicalpark Seyhan Hospital

    Seyhan, Adana, 01140

    Recruiting

Other trials in Turkey (Türkiye)

South Korea10 sites, 10 recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601

    Recruiting

  • National Cancer Center

    Gyeonggi-do, Gyeonggi-do, 10408

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, Seoul, 21565

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center, Univ. of Ulsan

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 135-720

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Recruiting

  • Korea University Guro Hospital

    Seoul, 8308

    Recruiting

Other trials in South Korea

Taiwan7 sites, 7 recruiting

  • Changhua Christian Hospital

    Changhua, Changhua City, 500

    Recruiting

  • Chi Mei Medical Center

    Tainan, 71004

    Recruiting

  • Mackay Memorial Hospital

    Taipei, 10449

    Recruiting

  • National Taiwan University Hospital

    Taipei, 106

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11211

    Recruiting

  • Tri-Service General Hospital

    Taipei, 114202

    Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei, 116

    Recruiting

Other trials in Taiwan

Canada6 sites, 6 recruiting

  • Centre de Santé et de Services Sociaux de la Montérégie-Centre

    Greenfield Park, Quebec, J4V 2H1

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Research Institute - McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval

    Québec, G1J 0J9

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Recruiting

Other trials in Canada

About this study

Official title: Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants who have advanced ovarian cancer.

The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegylated liposomal doxorubicin [PLD]), referred to as "combination drugs'.

Read more

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug and its experimental combinations
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations
Being tested
Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Keywords
Cancer of the Fallopian Tube, Cancer of the Ovary, Fallopian Tube Carcinoma, Fallopian Tube Neoplasm, Fallopian Tube Neoplasms, Ovarian Carcinoma, Ovarian Neoplasms, Peritoneal Cancer, Peritoneal Neoplasms, Platinum Resistance, PPC, Primary Peritoneal Carcinoma
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UbamatamabDrug

    Also called REGN4018

    Administered per the protocol

  • BevacizumabDrug

    Also called Avastin®

    Administered per the protocol

  • CemiplimabDrug

    Also called Libtayo®, REGN2810

    Administered per the protocol

  • FianlimabDrug

    Also called REGN3767

    Administered per the protocol

  • PLDDrug

    Also called Doxil®, Pegylated liposomal doxorubicin

    Administered per the protocol

  • SarilumabDrug

    Also called Kevzara®, REGN88, SAR153191

    Administered per the protocol

  • REGN10597Drug

    Also called PD-1-IL2Ra-IL2 immunotherapy

    Administered per the protocol

Study groups in NCT06787612
Study groupRoleWhat they receive
Arm A1ExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm A2ExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm BExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Bevacizumab; Drug: Sarilumab
Arm CExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Cemiplimab; Drug: Fianlimab; Drug: Sarilumab
Arm DExperimentalNot described
Receives: Drug: Ubamatamab; Drug: PLD; Drug: Sarilumab
Arms E1/E2ExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Sarilumab; Drug: REGN10597
Arm FaExperimentalNot described
Receives: Drug: Ubamatamab
Arm GaExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm FbExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Bevacizumab
Arm GbExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Bevacizumab; Drug: Sarilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment

    Measured: Up to 3 years

Secondary outcomes (19)

  1. Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria

    Measured: Up to 3 years

  2. Complete Response (CR) rate by RECIST 1.1

    Measured: Up to 3 years

  3. Disease Control Rate (DCR) by RECIST 1.1

    Measured: Up to 3 years

  4. Duration of Response (DOR) by RECIST 1.1

    Measured: Up to 3 years

  5. Progression-Free Survival (PFS) by RECIST 1.1

    Measured: Up to 3 years

  6. Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria

    Measured: Up to 3 years

  7. Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to 3 years

  8. TEAEs by Lee criteria

    Measured: Up to 3 years

  9. Concentration of ubamatamab in serum

    Measured: Up to 3 years

  10. Concentration of fianlimab in serum

    Measured: Up to 3 years

  11. Concentration of REGN10597 in serum

    Measured: Up to 3 years

  12. Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab

    Measured: Up to 3 years

  13. Magnitude of ADA to ubamatamab

    Measured: Up to 3 years

  14. Occurrence of ADA to fianlimab

    Measured: Up to 3 years

  15. Magnitude of ADA to fianlimab

    Measured: Up to 3 years

  16. Occurrence of ADA to cemiplimab

    Measured: Up to 3 years

  17. Magnitude of ADA to cemiplimab

    Measured: Up to 3 years

  18. Occurrence of ADA to REGN10597

    Measured: Up to 3 years

  19. Magnitude of ADA to REGN10597

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start28 May 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
397 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787612
Sponsor's protocol ID
R4018-ONC-2445
Other IDs
2024-517806-27-00
Status last verified
Oct 2026
First submitted
16 Jan 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ubamatamab, Bevacizumab and Cemiplimab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Regeneron Pharmaceuticals at 56 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Turkey (Türkiye), South Korea, Taiwan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06787612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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